
Aspen Laboratories, Inc.
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BISTAT ELECTROSURGICAL UNIT 60-5400-001 is an FDA 510(k)-cleared medical device (K896838) manufactured by Aspen Laboratories, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1990. Regulation: 8.